Novel Critical Path Focus on Obligatory DrugDevice Interactions: FDA CDER View –
Drug-Device Safety
Cardiovascular Research Technologies (CRT)
FDA Town Hall
February 23, 2010
Karen A. Hicks, MD
Medical Officer
Division of Cardiovascular and Renal Products (DCRP),
Center for Drug Evaluation and Research (CDER),
U.S. Food & Drug Administration
1
DISCLOSURES
Karen A. Hicks
I have no real or apparent conflicts of
interest to report.
FDA’s Critical Path Initiative
 Launched in March 2004 (release of FDA’s
Landmark Report: Innovation/Stagnation:
Challenge and Opportunity on the Critical
Path to New Medical Products)
 Represents FDA’s national strategy for
driving innovation to modernize the sciences
through which FDA-regulated products are
developed, evaluated, manufactured, and
used
3
Critical Path Initiatives
 Standardized Data Collection for
Cardiovascular Trials
 FDA’s Sentinel Initiative
 DAPT-DES (Dual Anti-Platelet Therapy
and Drug Eluting Stents)
 SAFARI (Safety of Atrial Fibrillation
Ablation Registry)
 TREAT (Trans-Radial Education,
Assessment & Training)
4
Why Data Standards?
 To improve the quality and efficiency of
cardiovascular trials
 To provide endpoint definitions so that
events are clearly characterized by objective
criteria and reported uniformly
 To standardize data collection to capture key
data elements
 To simplify analysis of events in drug
development programs or among different
clinical trials and to more easily identify
trends and other safety signals
5
Goals of Initiative
 Standardized Definitions
 Standardized Data Collection/Case Report
Forms
 Integrate with
 CDISC (Clinical Data Interchange Standards
Consortium)

SDTM: Study Data Tabulation Model
 HL7 (Health Level 7, Inc.)
 FDA Data Warehouse of Cardiovascular
Trials
6
Stakeholders - 1
 FDA (CDER, CDRH, Office of Women’s Health)
 CDER Data Standards (Jay Levine,
Ana Szarfman)
 Critical Path Initiative (Leonard Sacks)
 Academia (Cleveland Clinic, CRF, DCRI, HCRI,
TIMI, BWH, St. Louis University)
 American College of Cardiology (ACC)
(James Tcheng, Dan Roman, Susan Fitzgerald)
 Association of Clinical Research Organizations
(ACRO) (Doug Peddicord, Christine Clark,
7
Jean Morgan, Barbara Tardiff)
Stakeholders - 2
 Clinical Data Interchange Standards
Consortium (CDISC) (Bron Kisler, Rebecca
Kush)
 Clinical Trials Transformation Initiative (CTTI)
(Judith Kramer)
 Health Level 7, Inc. (HL7) (Charles Jaffe)
 NHLBI (Mike Domanski)
 Pharmaceutical Research and Manufacturers
of America (PhRMA) (Alan Goldhammer)
 Pharmaceutical Industry Representatives
(Paul Burton (J & J), and Yale Mitchel (Merck))
8
Neurology Working Group
 Joseph Broderick, M.D.






(University of Cincinnati)
Cheryl Bushnell, M.D., MHS
(Wake Forest)
Donald Easton, M.D. (UCSF)
Larry Goldstein, M.D. (Duke)
Scott Kasner, M.D.
(University of Pennsylvania)
Walter Koroshetz, M.D.
(NIH/NINDS)
Joanne Odenkirchen, MPH
(NIH/NINDS)
 Natalia Rost, M.D. (Mass




General Hospital)
Cathy Sila, M.D. (Case
Medical Center)
Jeffrey Saver, M.D. (UCLA)
Scott Janice, M.D.
(NIH/NINDS)
FDA Stroke Team (Drs. Billy
Dunn, Heather Fitter, John
Marler, and Kachikwu Illoh)
9
Acknowledgements












Robert Temple, M.D. (CDER)
Norman Stockbridge, M.D., Ph.D. (DCRP)
Shari Targum, M.D. (DCRP)
Jim Hung (Director, Division of Biometrics I)
Andrew Farb, M.D. (CDRH)
Salma Lemtouni, M.D., MPH (OWH)
Mary Parks, M.D. (DMEP)
Hylton Joffe, M.D., M.M.Sc (DMEP)
Ilan Irony, M.D. (DMEP)
Rachel Hartford, RPM (DMEP)
Chuck Cooper, M.D. (OTS/OB/DBVI) and Marni Hall (OD)
FDA Stroke Team (Billy Dunn, M.D., Heather Fitter, M.D.,
John Marler, M.D., Kachikwu Illoh, M.D.)
10
Standardized Data Collection
for Cardiovascular Trials
Coming Soon
11